Coatings may be applied to medical devices to provide certain advantages or functionality. For example, a coating may increase the lubricity of the surface of a medical device and/or serve as a reservoir for a bioactive substance.
A catheter is an example of a medical device that may benefit from a coating. Catheters are elongated, flexible tubular instruments that may be inserted into a body cavity or blood vessel and maneuvered to a desired site for diagnostic or therapeutic purposes. In order to minimize friction, thrombosis, tissue trauma, tissue adhesion, and/or other effects, it may be beneficial to coat the surface of a catheter with a lubricious coating. If the catheter has a therapeutic purpose, it may be desirable to apply a coating that is capable of containing and releasing a bioactive agent.
Conventionally, the application of a coating to a medical device such as a catheter entails a number of labor-intensive processing and handling steps. In one conventional process, a continuous length of extruded tubing may be cut into one or more tubes prior to application of the coating. Each tube may further undergo forming or bonding operations before the coating is applied. Plugs may be inserted into the ends of each tube to prevent the coating from penetrating into the inner core, or lumen, of the tube during the coating process. Each plugged tube may be placed onto a fixture for transfer to a coating tank for application of the coating. After the coating has been applied, each plugged tube may be transferred to another location for removal of the fixture and plugs. Additionally, the removed plugs may undergo a cleaning process to eliminate the coating residue before being returned to production. The insertion and removal of the plugs from each tube, the placement of each tube in and its removal from the fixture, and the cleaning of the plugs are typically carried out manually. In a high-volume manufacturing environment, one hundred thousand or more tubes may require such handling each month.
Thus, the overall efficiency of the process to produce coated medical devices could be improved by eliminating labor-intensive processing and handling steps.